(33 days)
Norian SRS Bone Void Filler is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Norian SRS Bone Void Filler is intended to be placed or injected into bony voids or gaps of the skeletal system (the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Norian SRS Bone Void Filler is an injectable, moldable, and biocompatible bone void filler. The Reactants Pack contains sterile powder (calcium phosphate) and a syringe that contains sterile solution (dilute sodium phosphate). The Reactants Pack is designed to be placed in a reusable mixer where the 2 components are mixed together to form a smooth, viscous paste that remains injectable for approximately 5 minutes at 18°-23°C / 64°- 73°F. At body temperature (37°C / 98.6°F), Norian SRS Bone Void Filler begins to harden after 2 minutes and sets in approximately 10 minutes. Norian SRS Bone Void Filler is slowly resorbed and replaced by bone over a period of years.
The provided text is a 510(k) summary for the Norian SRS Bone Void Filler. This document describes a medical device and its intended use, but it does not contain information about acceptance criteria, device performance studies, or ground truth establishment for an AI/CADe device.
The document states: "Norian SRS Bone Void Filler is equivalent to the predicate device in terms of material composition, physical properties, and performance characteristics." This implies that the device's performance was compared to a previously approved predicate device, but it does not detail any specific acceptance criteria or a study design like those typically associated with evaluating AI/CADe systems.
Therefore, I cannot fulfill your request for information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided text. This information is usually found in performance data sections of 510(k) submissions for AI/CADe devices, which this document is not.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.